TriangleNCT04730349 · OUTCOME
Number of Participants With Adverse Events Leading to Discontinuation - Part A
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose to 30 days after last dose (up to approximately 6 months)
What was measured
Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Analysis population: All treated participants in Part A
Groups in this outcome
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
| Group | Source count |
|---|---|
| Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) | 8 |
| Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- groups
- description
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
- id
- OG000
- title
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
- description
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
- id
- OG001
- title
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants in Part A
- reporting Status
- POSTED
- time Frame
- From first dose to 30 days after last dose (up to approximately 6 months)
- title
- Number of Participants With Adverse Events Leading to Discontinuation - Part A
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice